Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Fondren Orthopedic Group L.L.P.
Sponsor:
Collaborator:
InGeneron, Inc.
Information provided by (Responsible Party):
Fondren Orthopedic Group L.L.P.
ClinicalTrials.gov Identifier:
NCT01799876
First received: February 22, 2013
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.


Condition Intervention
Articular Cartilage Defect Grade III or IV of the Knee
Procedure: Autologous Cell
Procedure: Standard microfracture arthroscopic surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Cell Therapy Enhancement of Microfracture Surgery

Further study details as provided by Fondren Orthopedic Group L.L.P.:

Primary Outcome Measures:
  • Magnetic Resonance Imaging (MRI) for osteochondral defect filling [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Filling will be scored by quartile with 1 point for less than 25% filling of the defect and 4 points for greater than 75% filling. Evaluated by radiologist who is blinded to group assignment.


Secondary Outcome Measures:
  • Pain Scores on Numerical Rating Scale [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Knee Injury and Osteoarthritis Outcomes Survey (KOOS) [ Time Frame: 12 months postop ] [ Designated as safety issue: No ]
    Survey

  • Knee Range of Motion [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Number of Patients with Adverse Events as a Measure of Safety [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Cell
Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
Procedure: Autologous Cell
Sham Comparator: Control
Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).
Procedure: Standard microfracture arthroscopic surgery

Detailed Description:

Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study.

Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients.

Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects undergoing microfracture surgery for the repair of articular cartilage
  • Osteochondral defect Grade III or IV
  • Age 18 to 68 years
  • Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate
  • Written informed consent
  • Ability to speak, read and write English or Spanish

Exclusion Criteria:

  • Inability to speak, read and write English or Spanish
  • Evidence of malignant disorder/neoplasm in past 24 months
  • History of basal cell carcinoma
  • History of smoking and not committed to give up
  • Chronic skin conditions
  • Connective, metabolic or skin disease
  • Evidence of active infection
  • Pregnancy or lactating for female subjects
  • Diabetes Type I or II
  • Current steroid use
  • Immunosuppressive medication
  • Renal failure (creatine > 1.8 mg/dL)
  • Hepatic failure (AST, ALT >2 times normal values; bilirubin >2.0 mg/dL)
  • Inflammatory joint diseases of the knee that indicate additional, conflating therapies
  • Joint infection within the past 6 months
  • Meniscal resection of greater than 50% prior to, or at time of procedure
  • Uncorrected joint instability
  • Joint malalignment > 5 degrees
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799876

Contacts
Contact: Robert L Burke, MD 713-436-3488 mc104@fondren.com
Contact: Mai-Ling Camacho 713-436-3488 mc104@fondren.com

Locations
United States, Texas
Fondren Orthopedic Group, L.L.P. Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Robert L Burke, MD         
Sponsors and Collaborators
Fondren Orthopedic Group L.L.P.
InGeneron, Inc.
Investigators
Principal Investigator: Robert L Burke, MD Fondren Orthopedic Group L.L.P.
  More Information

No publications provided

Responsible Party: Fondren Orthopedic Group L.L.P.
ClinicalTrials.gov Identifier: NCT01799876     History of Changes
Other Study ID Numbers: FOG-TOH125
Study First Received: February 22, 2013
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Fondren Orthopedic Group L.L.P.:
knee
cartilage
microfracture
cell therapy

ClinicalTrials.gov processed this record on July 28, 2014